SYBRONENDO

Additional Manufacturer Narrative

NO PATIENT INFORMATION WAS PROVIDED IN REGARDS TO WEIGHT, ETHNICITY, AND RACE. DATE OF EVENT WAS NOT PROVIDED. NO INFORMATION WAS PROVIDED IN REGARDS TO THE SERIAL NUMBER, THEREFORE DEVICE MANUFACTURING DATE COULD NOT BE DETERMINED. THIS WILL BE TWENTY-THREE (23) OF TWENTY-FOUR (24) MEDICAL DEVICE REPORTS THAT WILL BE SUBMITTED. THE PRODUCT HAS BEEN IDENTIFIED AS AN AFFECTED PRODUCT IN AN ONGOING CLASS II RECALL; THEREFORE NO FURTHER EVALUATION IS NECESSARY.

Description of Event or Problem

AN ALLEGED COMPLAINT WAS REPORTED THAT MULTIPLE PATIENTS SUFFERED A TOUGHER POST-OPERATIVE RECOVERY. THEY FELT A VERY HIGH SENSITIVITY DUE TO HIGHER HEAT.